BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CoNextions TR Tendon Repair System

    K Number: K203855 · Decision Apr 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    31
    Applicant Total
    2
    Review Days
    477

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    Basic Information

    Device Name
    CoNextions TR Tendon Repair System
    K Number
    K203855
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4495
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Conextions Medical
    Date Received
    December 31, 2020
    Decision Date
    April 22, 2022
    Product Code
    GAQ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GAQ Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile

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